In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.

Unchanged outcome = proportion of infants with a recurrence of infection requiering additional courses of antibiotic therapy within 72 hours after ending antibiotic therapy and/or death in the first month of life

In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.Antibiotic therapy can be continued despite fulfilled criteria at the discretion of the attending physician. These divesions from the stopping rules will be reported for further analysis.

Other: Procalcitonin-guided decision making

In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.

Other Name: Procalcitonin-guided duration of antibiotic therapy

No Intervention: Standard group

The duration of antibiotic treatment in the standard group is based on the attending physician's assessment of the risk of classification: infection unlikely for 36-72 hours, infection possible for 5-7 days, infection probable of proven for 7-21 days depending on clinical course, laboratory values and positive cultures.

Detailed Description:

Detailed description according our pilot study (see reference). This trial is designed to exclude a difference in rate of re-infection or death greater than 2%. Assuming a 2% reinfection/death rate in each group, 770 patients are required for a power of 80% at alpha=0.05. To allow for some unevaluable cases 800 per group will be included. Based on the data of the pilot study (see reference), with a number of 770 per group a difference between mean antibiotic therapy durations of 10 hours can be detected at two-sided alpha of 0.05 with a power of 95%.

Eligibility

Ages Eligible for Study:

up to 3 Days

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Term and near term infants with a gestational age > 34 weeks

Suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy

Parental consent

Exclusion Criteria:

Surgery in the first week of life

Severe congenital malformations

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854932